Hims is breaching the US patent on semaglutide, the active ingredient in Novo’s blockbuster obesity treatments, Novo argued Monday. The US lawsuit attacks not only Hims’ new strategy to launch a copycat pill but also goes after shots that mimic Wegovy and its sister drug Ozempic.
The move marks a more aggressive approach for Novo under Chief Executive Officer
The Danish pharmaceutical company itself ran afoul of regulators when it comes to the obesity pill. The
“We take all regulatory feedback seriously and are in the process of responding to the FDA to address their concerns regarding the advertisement’s presentation,” Novo spokesperson Liz Skrbkova said in an email.
Increasing Tensions
The lawsuit escalates Novo’s spat with Hims despite the telehealth company’s retreat on Saturday, when it said it would stop offering cheaper versions of the new Wegovy pill meant to fuel the Danish drugmaker’s
It followed a turbulent week for Novo. First the drugmaker issued a
Hims shares fell 24% at 12:06 pm in New York, the most in almost eight months. Novo surged as much as 9% on Monday after Hims scrapped the Wegovy pill copycats, then pared gains after news of the lawsuit and the FDA letter emerged.
The Hims decision to launch a knock-off Wegovy pill was “a step too far,”
The two companies scrapped a partnership last year and their relationship has grown increasingly acrimonious. Novo said its medicines are produced in accordance with US Food and Drug Administration requirements, following strict safety controls, in contrast to the Hims ones.
The Novo lawsuit is “a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care,” Hims said in a statement. “Once again, Big Pharma is weaponizing the US judicial system to limit consumer choice.” The company pledged to fight to provide “choice, affordability, and access.”
Patient Health
“Hims has engaged in promotional campaigns that highlight its compounded semaglutide products, duping consumers and health-care professionals as to the clinical benefits and safety of these unapproved drugs,” Novo said in a statement. The knock-offs, it argued, “are putting patient health and wellbeing at risk.”
The lawsuit, which Novo said it filed in Delaware, alleges that Hims products including its weight-loss injections are compounded forms of semaglutide and therefore infringe on Novo’s patent.
Hims had knowledge of the patent, which has been infringed since 2024, Novo argues. The company is seeking damages for what Kuckelman described as “reasonable royalties” and lost profit. The drugmaker said it had sent a letter to Hims on Feb. 8 raising the infringement and demanding the telehealth company cease producing these products.
Supply Shortage
Hims abandoned the plan over the weekend following US government threats. The decision didn’t stop Novo from launching the case, whose scope extends beyond the pill to all uses of semaglutide, which is also injected.
Novo has seen its market capitalization fall from more than $600 billion in 2024, when it was briefly the most valuable company in Europe, to about $227 billion.
The makers of blockbuster GLP-1 drugs, Novo and Lilly, have long complained the US Food and Drug Administration hasn’t done enough to stop the proliferation of cheap, compounded weight-loss drugs. Telehealth companies were first able to sell knock-off obesity medicines during a supply shortage a few years ago. The shortage has ended, but the practice has continued.
“We believe it’s a complete sham that they say so many patients need personalized compounding of semaglutide post shortage,” Kuckelman said.
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Novo is trying to work with compounders to get them to sell the branded products, according to Kuckelman. “But unfortunately, you have Hims, which is a very big player, who rather than doing the right thing, they’ve just decided that they’re above the law and they can continue to sort of thumb their nose at the FDA and other regulators,” he said.
The FDA on Friday pledged to act against copycat weight-loss drugs. The Department of Health and Human Services also said it referred Hims to the Department of Justice for possible violations of federal law. The FDA’s firmer stance comes after Novo and Lilly agreed to cut prices in deals with the US government.
Marketing Complaints
While regulators appeared to side with Novo last week, the agency still took issue with the way the Danish drugmaker has been marketing its new weight-loss pill. In a
The FDA said the television spot “misleadingly” suggests that Wegovy in its pill form offers an advantage over other weight-loss drugs. The agency took specific issue with the lines “live lighter” and “a way forward,” which appeared in the ad, according to the letter.
“Additionally, they misleadingly imply benefits beyond physical weight loss such as emotional relief, reduced psychological burden, hope, or direction for patients’ lives, positioning the drug as a solution to broader life challenges rather than a treatment for a specific condition,” the FDA said.
The agency issued a flurry of letters to drug companies last year as part of the Trump administration’s push to crack down on pharmaceutical advertising.
(Adds FDA letter to Novo in the fourth paragraph, the company’s response in the fifth paragraph.)
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Marthe Fourcade, Michelle Fay Cortez
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